Duarte, California 91010


Purpose:

This partially randomized pilot clinical trial develops and studies a software program, called PatientCareAnywhere, to see whether it can help patients communicate with their doctors and other healthcare providers, and educate themselves about their cancer and treatment options. A program that can help patients learn about their cancer and treatment options, and allows the patient's healthcare providers to receive their questionnaire results, may help patients identify and get help to treat their symptoms.


Study summary:

PRIMARY OBJECTIVES: I. Solicit stakeholder feedback on expected system functions, perceived usefulness and impacts, and potential adoption barriers via 10 focus groups. (Human Subjects [HS], Phase I) II. Develop the software prototype using an iterative user-centered design process and leverage the technical design and components from an existing clinic-based biopsychosocial screening tool and an existing patient portal solution as well as the patient education contents from City of Hope (COH). (Phase I) III. Conduct two usability tests with 24 subjects each to evaluate the usability, usefulness, and acceptability of the prototype system developed in Aim 2. (HS, Phase I) IV. Conduct a 50-subject pilot evaluation study to demonstrate the feasibility of our technical solution and our Phase II randomized controlled trial protocol design. (HS, Phase I) V. Enhance the software system to add more administrative/customization features and to expand the education contents to cover more cancer types and treatment options. (Phase II) VI. Conduct a 2-year 516-subject randomized control trial to test the effectiveness hypothesis. (HS, Phase II) OUTLINE: FOCUS GROUPS: Ten, 90-minute focus group sessions are conducted, composed of patients; caregivers, friends, and family members; cancer treatment professionals; supportive care professionals and community support professionals. Sessions address what functions participants expect to see in the program, what benefits are expected, and any expected barriers for using the program. USABILITY EVALUATION (DESIGN-ORIENTED & METRIC-ORIENTED): Patients, caregivers, and clinical care/support professionals in each type of evaluation undergo a 60-minute one-on-one session in which they are assigned tasks to complete using the system, and an observer records how the tasks are completed. Participants are also requested to talk aloud while performing the task. Participants in the metric-oriented evaluation respond to usability and usefulness questionnaires. PILOT STUDY & RANDOMIZED CONTROLLED TRIAL: Patients are randomized to 1 of 2 arms. ARM I (INTERVENTION GROUP): Patients are encouraged to use the PatientCareAnywhere program at least once weekly either in the clinic or at home. Patients receive reminder emails after 1 week of inactivity. If patients indicate they are experiencing moderate to severe symptoms, an alert message is sent to at least 1 member of the patient's support team along with a list of expected response times. ARM II (CONTROL GROUP): Patients receive usual care, including a one-time use of SupportScreen, a touchscreen questionnaire system that identifies patient issues before appointments, at the clinic during the first treatment consultation after diagnosis. Consultation, printed education materials, and specialist referrals may be generated based on SupportScreen responses.


Criteria:

Inclusion Criteria: Stakeholder and Usability Study: - Malignant diagnosis in any cancer type at any stage - Receiving any type of cancer treatment - Life expectancy of at least six months - Current outpatient status - Fluent in English - Internet access at home Pilot Study: - Malignant diagnosis in breast, gynecologic (GYN), genitourinary (GU) cancer at any stage - Receiving surgery and/or chemotherapy treatment - Life expectancy of at least six months - Current outpatient status (participation will be suspended during hospitalization) - Fluent in English - Internet access at home Randomized Controlled Trial: - Malignant diagnosis in any cancer type at any stage - Receiving any type of cancer treatment - Life expectancy of at least six months - Current outpatient status (participation will be suspended during hospitalization) - Fluent in English - Internet access at home Exclusion Criteria: Stakeholder and Usability Study: - Clinical evidence of cognitive or psychological impairment - Prisoners - Pregnant women Pilot Study and Randomized Controlled Trial: - Clinical evidence of cognitive or psychological impairment - Prisoners - Pregnant women - Currently participating in other psychosocial studies


NCT ID:

NCT02408406


Primary Contact:

Principal Investigator
Matthew Loscalzo
City of Hope Medical Center


Backup Contact:

N/A


Location Contact:

Duarte, California 91010
United States

Matthew Loscalzo
Phone: 800-826-4673

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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